Scientific Clearance Manager Milano

Scientific Clearance Manager
Milano
Lombardia, Milano

Make your mark for patients.

We're here because we want to build the future and transform patients' lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive.

That's why we're looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients.

We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead.

Will you join us in pushing the boundaries of what's possible?

As a Scientific Clearance Manager, your main tasks will be:

- As CCC (Country Clearance Committee) member, provide support for implementation, review and approval of promotional and non-promotional materials according to local regulatory rules and in compliance with Company SOPs and Code of Conduct

- Local support for review and approval of promotional, communicational and scientific training tools for assigned therapeutic areas.

- Partnering and close cooperation with Global Clearance Committee

- Contributing to MedCom best practice development and sharing

- Collect and provide quantitative and qualitative metrics on MedCom activities

- Creation, monitoring and update of policies and processes related to Medical Affairs activity to ensure compliance with existing regulations, including but not limited to Medical Communication activities

- Anticipate new or changing regulations and coordinate with internal stakeholders to develop strategies to address changes in product, operations, labeling, requirements

- Support to PVUs for activities with regulatory impact

- Partnering in close cooperation with PVUs, and the Global teams for the continuous optimization of the approval process of all promotional, communicational and scientific training materials

- Responsible for training UCB employees regarding Farmindustria/AIFA and Medical Communication topics and tools

**The competences requested for the position are as followed**:

- Knowledge:_

1.

Sound knowledge of regulatory affairs in pharma industry (D. Leg 219/2006,

Farmindustria Code) ad proven by previous similar roles in pharmaceutical companies

2.

Broad knowledge of compliance rules and requirements in pharmaceutical industry as proven by similar roles covered in Pharma companies

3.

Proven expertise (at least 8 years) in regulatory revision of promo and non-promo

materials

4.

Extensive knowledge and advanced use of platforms for submission and approval of

documents and/or materials

5.

Advanced understanding of pharmaceutical product development, product lifecycle and

commercialization process

6.

English language oral / written at professional level

7.

Literature database searching: OVID, PUBMED, EMBASE

8.

Advanced usage of IS system

9.

Expertise in writing standard policies

10.

Preferred: specific knowledge at least in one relevant therapeutic area

**_

Competencies:_

1.

Project Management skills

2.

Working in team in a complex, multi-functional, global matrix environment

3.

Smart and problem-solving approach

4.

Ability to work under short deadlines

5.

Excellent communication and negotiation skills

6.

Analytic and pragmatic approach

**About us.

UCB is a global biopharmaceutical company, focusing on neurology and immunology.

We are around 7, 600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: "How will this create value for people living with severe disease? ".

We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives.

We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer.

We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.